SOP For Product Identification and Traceability

SOP For product identification and traceability is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

The purpose of this SOP is to define the method used for the identification of all contributing materials that could affect product quality, and to ensure their full traceability.

SCOPE

It establishes the method to provide control on all the records and documents used for the identification and traceability of incoming raw materials and outgoing finished goods.

This SOP is applicable to Quality Assurance, Warehouse, Quality Control and Production departments.

RESPONSIBILITY

Q.A Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE

On receipt of material in the Warehouse , the staff ensures that all the containers have proper identification labels reflecting details i.e. product name, name of manufacturer, quantity etc

The material thus checked is verified against the delivery documents and purchase order to confirm that the material is received accordingly.

Physical inspection of raw materials (sterile and non-sterile) is carried out according to the prescribed quality records in the presence of Quality Assurance Inspector & Dispensing Pharmacist.

The material is entered in material record register and lot number is allocated to each item. (“P” is added to lot number for packing materials & “R” is added for raw materials)

A Good Receive Note (GRN) will be generated if the checks are satisfactory.

GRN is prepared with all information regarding supplier, origin, item code, description,  no of containers, etc.

GRN and all relevant documents are filed after cross-referring the documents with each other (delivery challan, inward gate pass ) 

Material status (Quarantine) label is fixed on the container & is stored in Quarantine area.

After QC approval the material is issued for batch manufacturing to production in reference with MO (manufacturing order), having batch number.

This batch number is then the unique identification of the product upto the customers.

The samples of each batch of every product is retained by QAD and documented in QA Retained Sample Record.